(123 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire and its extension, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a guidewire intended to introduce and position other devices, not to provide a therapeutic effect itself.
No
The device is described as a guidewire used to introduce and position catheters and interventional devices, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components made of stainless steel, PTFE, and platinum, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in anqiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature." This describes a device used within the body for a medical procedure, not a device used outside the body to test samples (like blood, urine, or tissue) for diagnostic purposes.
- Device Description: The description details a physical guidewire and extension used for navigating blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples, detect biomarkers, or provide diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on physical and mechanical properties of the guidewire and its biocompatibility, which are typical for implantable or interventional medical devices, not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Lake Region's steerable quidewires are intended for use in anqiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The attachment of the guidewire extension to the Lake Region Steerable quidewire creates a quidewire that can be used to exchange a catheter without removing the guidewire from the vessel. When the exchange is complete, the quidewire extension can be detached and the original quidewire can aqain be used in a conventional manner.
Product codes
74 DQX
Device Description
The quidewire is a steerable PTFE coated stainless steel core wire; the distal portion may be either a 30 cm long stainless steel outer coil with a 2 cm long platinum inner coil to provide radiopacity, or a 30 cm long platinum coil for radiopacity; the tip may be either a straight, shapable configuration or a preshaped J The quidewires are coated with MDX configuration. The quidewires are bound by the following (silicone). parameters:
Outside Diameters: . 014" - . 018" 175 cm - 300 cm Lengths: Straight, Shapable and J Tips: Flexibility: Floppy to Support
The quidewire extension is a PTFE coated stainless steel wire with a connector at the distal end and is bound by the following parameters:
Outside Diameter: .014" - .018" Length: 145 cm
The alignment tool is a slit rubber or silicone cylinder which assists in the placement of the quidewire pin into the extension connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
LRM performed physical/mechanical testing to support this submission. Within each product group, there were twenty (20) samples selected. The following tests were performed:
- Dimensional Measurement: Micrometer measurement of the outside diameter of the guidewire at multiple body points.
- Distal Tip Flexibility: Assess the flexibility of a distal tip.
- Torsional Integrity: Assess the torqueable strength of a quidewire.
- Coating Durability: Measures the number of controlled abrasion strokes necessary to cause deformation or removal of PTFE coating.
- Rotational Control: Assess guidewire rotational control (clockwise or counter clockwise) to allow placement of the distal tip at a desired location in a 360°circle when controlled from the proximal end of the guidewire.
- Guidewire Pull Test: Measures the strength of the joints of the guidewire.
- Three Point Bend: Measures stiffness/flexibility of quidewire body.
- Extension Joint Coupling: Assess ease of joint connection.
- Catheter/Extension Joint Interface: Confirm clearance and smooth transition of extension joint relative to the catheter.
- Extension Joint Integrity: extended Assess quidewire joint functionality.
All test results were within prescribed specification limits.
Biocompatibility testing was also performed, adapting the recommendations in the FDA's DRAFT "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993.
- Acute Systemic Toxicity: No signs or symptoms of Systemic Toxicity were observed for any of the samples
- Cytotoxicity: The sampled passed per current USP
- Hemolysis: The samples did not produce hemolysis
- Intracutaneous Test: For all samples, skin reactions were not significant
- Physico-Chemical: The samples passed per current USP
- Thromboresistance: The samples were not considered thrombogenic
- Chemical Analyses: The samples meet specifications
- Pyrogen test: The products did not produce a pyrogenic response
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
SECTION 2.0 - SUMMARY & CERTIFICATION
JUN - 6 1997
- General Information 2.1
- Company name, Address, and Telephone Number 2.1.1
Lake Region Manufacturing, Inc. (LRM) 340 Lake Hazeltine Drive Chaska, Mn 55318
Fax: 612/448-3441 612/448-5111 Telephone:
-
Device Trade Name/Proprietary Name 2.1.2
produce guidewires on an OEM basis for other LRM manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission. -
Device Common Names/Unusual Names, Classification Names 2.1.3
These devices are commonly known as coronary catheter guidewires and accessories. -
LRM Establishment Registration Number: 2126666 2.1.4
-
2.1.5 Classification of Devices
Catheter guidewires have been classified as Class II be the Circulatory Systems Devices Panel (reference 21 CFR 870.1330).
- 2.1.6 Applicability of Performance Standards
determined that no mandatory performance LRM has standards have been established for these devices under Section 514 of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act or by any subsequent requlatory action.
1
Labels, Labeling, and Advertising 2.2
LRM produces cardiovascular and vascular guidewires on an OEM for other manufacturers, kit assemblers, and and basis distributors. Changes to the customer controlled labels, labeling, or promotional material are at their discretion, including the resolution of any resulting regulatory obligations.
A small fraction of the total production bears LRM controlled labels and labeling.
-
2.3 Summary of Safety and Effectiveness
This summary is being provided included in the Premarket Notification submission in lieu of a statement of availability. -
Device Description 2.4
-
2.4.1 Description of Guidewires
The quidewire is a steerable PTFE coated stainless steel core wire; the distal portion may be either a 30 cm long stainless steel outer coil with a 2 cm long platinum inner coil to provide radiopacity, or a 30 cm long platinum coil for radiopacity; the tip may be either a straight, shapable configuration or a preshaped J The quidewires are coated with MDX configuration. The quidewires are bound by the following (silicone). parameters:
Outside Diameters: . 014" - . 018" 175 cm - 300 cm Lengths: Straight, Shapable and J Tips: Flexibility: Floppy to Support
- 2.4.2 Description of the Guidewire Extension and Alignment Tool
The quidewire extension is a PTFE coated stainless steel wire with a connector at the distal end and is bound by the following parameters:
Outside Diameter: .014" - .018" Length: 145 cm
The alignment tool is a slit rubber or silicone cylinder which assists in the placement of the quidewire pin into the extension connector.
- 2.4.3 Engineering Specifications
The design specifications are the same for the products offered by LRM as when they were offered by Baxter. The finished devices must meet the same design criteria. Additional diameter offerings in the .016" and .018" range have been added to the product options. Section 2.5 contains comparative data.
2
Substantial Equivalence Data 2.5
Background Information 2.5.1
In order to demonstrate equivalence of the products, LRM performed physical/mechanical testing to support this submission.
-
2.5.2 Test Data
Within each product group, there were twenty (20) samples selected. The following tests were performed: -
Dimensional Measurement: Micrometer measurement of 2.5.2.1 the outside diameter of the guidewire at multiple body points.
-
Assess the flexibility of Distal Tip Flexibility: 2.5.2.2 a distal tip.
-
torqueable Assess the Torsional Integrity: 2.5.2.3 strength of a quidewire.
-
Durability: Measures the number of 2.5.2.4 Coating controlled abrasion strokes necessary to cause deformation or removal of PTFE coating.
-
Rotational Control: Assess guidewire rotational 2.5.2.5 control (clockwise or counter clockwise) to allow placement of the distal tip at a desired location in a 360°circle when controlled from the proximal end of the guidewire.
-
Guidewire Pull Test: Measures the strength of the 2.5.2.6 joints of the guidewire.
-
Measures stiffness/flexibility 2.5.2.7 Three Point Bend: of quidewire body.
-
Assess ease of joint 2.5.2.8 Extension Joint Coupling: connection.
-
Catheter/Extension Joint Interface: Confirm 2.5.2.9 clearance and smooth transition of extension joint relative to the catheter.
-
Extension Joint Integrity: extended Assess 2.5.2.10 quidewire joint functionality.
-
All test results were within prescribed specification RESULTS : limits.
3
2.6 Qualification and Test Data
Material/Product/Process Qualification 2.6.1
LRM has formal quality systems in place to assure that each of the products manufactured remain equivalent to the predicate products and that there will be no adverse affects on the safe and effective use of the products. the quality systems include Engineering Change Order Review, Material Qualification, Product Qualification, and Process Qualification. These controls are applies to each product size/group.
2.6.2 Biocompatibility Testing
biocompatibility LRM has adapted the testing recommendations in the FDA's DRAFT "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993.
The following table lists the tests that were performed and the test results.
| TEST PERFORMED | TEST RESULTS |
|---|---|
| Acute Systemic Toxicity | No signs or symptoms of Systemic |
| Toxicity were observed for any of | |
| the samples | |
| Cytotoxicity | The sampled passed per current USP |
| Hemolysis | The samples did not produce |
| hemolysis | |
| Intracutaneous Test | For all samples, skin reactions |
| were not significant | |
| Physico-Chemical | The samples passed per current USP |
| Thromboresistance | The samples were not considered |
| thrombogenic | |
| Chemical Analyses | The samples meet specifications |
| Pyrogen test | The products did not produce a |
| pyrogenic response |
4
2.7 Packaging and Sterilization Information
LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is limited direct distribution by LRM. A portion of the production is private label, single packaged to customer specifications, a portion of that product is provided sterile to the customer.
The single packaged guidewire and extension wire are placed in a polyethylene dispensers and then into a Tyvek®/poly pouch. The product may be packaged as five (5) pouches in a shelf carton (five pack), which is a typical packaging configuration.
There will be no changes to the sterilization process for the portion of the product shipped sterile to the customer. for product that is shipped bulk, the packaging design and sterilization process parameters are the customer's responsibility. ¯ LRM will not recommend that its customers modify the packaging or sterilization procedures as a result of this submission.
5
Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Ms. Kim Aves Lake Region Manufacturing, Inc. ---------------------------------------------------------------------------------------340 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: %K970376 PTCA Guidewire Requlatory Class: II (two) Product Code: 74 DQX Dated: April 3, 1997 Received: April 4, 1997
Dear Ms. Aves:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
6
Page 2 - Ms. Kim Eves
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. ( allahan, Ph.I Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(K) Number (if known): Unknown
Steerable Guidewire and Extension Wire Device Name:
Indications for Use:
Lake Region's steerable quidewires are intended for use in anqiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The attachment of the guidewire extension to the Lake Region Steerable quidewire creates a quidewire that can be used to exchange a catheter without removing the guidewire from the vessel. When the exchange is complete, the quidewire extension can be detached and the original quidewire can aqain be used in a conventional manner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ta A- R
(Division Sign-Off Division of Cardiovascular, Respirato and Neurological Devices 510(k) Number
Prescription Use x (Per 21 CFR 801.109)
OR
Over-The-Counter Use